CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00003
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- September 15, 2010
- Report Date
- October 25, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT EXPERIENCED RESTENOSIS APPROXIMATELY SIX MONTHS POST IMPLANTATION OF THREE CYPHER STENTS. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING LVEF 40 - 50% AND COLON CANCER. THE INDICATION FOR THE PROCEDURE WAS POSITIVE FUNCTIONAL STUDY, SILENT ISCHEMIA AND ANGINA. (B)(6) 2010, THE MID LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, SEVERELY/HEAVILY CALCIFIED, NOT TORTUOUS, 3.0 MM VESSEL DIAMETER, 35 MM LENGTH, MID, A 90% STENOSIS, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON CATHETER AT 12 ATM. THREE (3) CYPHER STENTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD)-A 2.5 X 28 MM (STENT #1), A 2.5 X 23 MM (STENT #2), AND A 3.0 X 23 MM (STENT #3). THE THREE CYPHER STENTS WERE IMPLANTED IN THE TARGET LESION AT 16 ATM. IN OVERLAPPING FASHION. THE STENTS WERE POST-DILATED. THE RESIDUAL STENOSIS WAS 30%. THE FLOW PRE-PROCEDURE WAS TIMI 2 AND POST-PROCEDURE TIMI 3. ADDITIONALLY, A XIENCE 3.0 X 28 MM STENT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX. POST PROCEDURE CARDIAC ENZYMES WERE NOTED TO BE ELEVATED. THIS EVENT WILL BE CAPTURED AS AN MI. NO FURTHER TREATMENT WAS GIVEN AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON DUAL ANTI-PLATELET THERAPY. AT THE SIX-MONTH FOLLOW-UP CONTACT (B)(6) 2010, THE PATIENT WAS REPORTED TO HAVE HAD A RE-PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT THE MID LAD TARGET LESION DUE TO RECURRENT ANGINA. THE LAD STENTS APPEARED TO BE UNDERDEPLOYED. NO STENT THROMBOSIS WAS NOTED. THE EVENT WAS TREATED BY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) INCLUDING OPBA AND ONE NEW NON-STUDY STENT IMPLANTATION. THE EVENT WAS REPORTED TO BE RESOLVED WITHOUT SEQUELAE. THE ANTI-PLATELET REGIMEN WAS ALTERED; HOWEVER, THE PATIENT REMAINED ON DUAL ANTI-PLATELET THERAPY. THE STUDY STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE COMPLEXITY OF THE INDEX LESIONS TREATED. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 3003742446-2011-00001; 3003742446-2011-00002; AND 3003742446-2011-00003.
CORRECTED CC. A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED RESTENOSIS APPROXIMATELY SIX MONTHS POST IMPLANTATION OF THREE CYPHER STENTS. THE INDICATION FOR THE PROCEDURE WAS NON-ST SEGMENT ELEVATION ACUTE CORONARY SYNDROME. THE MID LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, SEVERELY/HEAVILY CALCIFIED, NOT TORTUOUS, 3.0 MM VESSEL DIAMETER, 35 MM LENGTH, MID, A 90% STENOSIS, AND TYPE B2. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON CATHETER AT 12 ATM. THREE (3) CYPHER STENTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD)-A 2.5 X 28 MM (STENT #1), A 2.5 X 23 MM (STENT #2), AND A 3.0 X 23 MM (STENT #3). THE THREE CYPHER STENTS WERE IMPLANTED IN THE TARGET LESION AT 16 ATM. IN OVERLAPPING FASHION. THE STENTS WERE POST-DILATED. THE RESIDUAL STENOSIS WAS 30%. THE FLOW PRE-PROCEDURE WAS TIMI 2 AND POST-PROCEDURE TIMI 3. ADDITIONALLY, A XIENCE 3.0 X 28 MM STENT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX. AT THE SIX-MONTH FOLLOW-UP CONTACT, THE PATIENT WAS REPORTED TO HAVE HAD A RE-PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT THE MID LAD TARGET LESION DUE TO RECURRENT ANGINA. THE EVENT WAS TREATED BY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE EVENT WAS REPORTED TO BE RESOLVED WITHOUT SEQUELAE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. CALCIFIED LESIONS ARE A COMMON CAUSE OF STENT UNDEREXPANSION WHICH SIGNIFICANTLY INCREASES THE SUBSEQUENT RISK OF IN-STENT RESTENOSIS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE VESSEL/LESION FACTORS (SEVERELY CALCIFIED, LONG LESION, 30% RESIDUAL STENOSIS) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 3003742446-2011-00001; 3003742446-2011-00002; AND 3003742446-2011-00003.
THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT # 3003742446-2011-00001; 3003742446-2011-00002; AND 3003742446-2011-00003. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FOR RECEIPT.
THE PATIENT WAS FOUND TO HAVE TWO-VESSEL DISEASE AND HAD TWO TARGET LESIONS AND ONE NON-TARGET LESION TREATED DURING THE INDEX PROCEDURE. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS MILDLY REDUCED (LVEF40-50%). THE MID LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, SEVERELY/HEAVILY CALCIFIED, NOT TORTUOUS, 3.0 MM VESSEL DIAMETER, 35 MM LENGTH, MID, A 90% STENOSIS, GREATER THAN TWO LESIONS PER VESSEL, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON CATHETER AT 12 ATM. THE THREE CYPHER STENTS WERE IMPLANTED IN THE TARGET LESION AT 16 ATM. IN OVERLAPPING FASHION. THE STENTS WERE POST-DILATED. THE RESIDUAL STENOSIS WAS 30%. THE FLOW PRE-PROCEDURE WAS TIMI 2 AND POST-PROCEDURE TIMI 3. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 3003742446-2011-00001; 3003742446-2011-00002; AND 3003742446-2011-00003.
ADJUDICATION MINUTES RECEIVED ON 10/25/2011 INDICATED THAT THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AT THE TIME OF THE PREVIOUSLY REPORTED RESTENOSIS ON (B)(6) 2011. REPEAT ANGIOGRAPHY ON (B)(6) 2010 FOR UNSTABLE ANGINA SHOWED AN EXTENSIVE STENTING THROUGHOUT THE PROXIMAL TO MID PORTION OF THE LAD, REVEALING 90 TO 95% CONCENTRIC RESTENOSIS WITHIN THE STENT. THE CATHETERIZATION REPORT NOTED THAT THERE WAS AN AREA OF CRIMPING NOTED AND IT APPEARED THAT THE PREVIOUS STENTS WERE SOMEWHAT UNDER-DEPLOYED. THE PATIENT UNDERWENT SUCCESSFUL PERCUTANEOUS REVASCULARIZATION WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A NON-STUDY DRUG-ELUTING STENT IN THE PROXIMAL LAD. THE REVASCULARIZATION WAS REPORTED TO BE UNCOMPLICATED. NO CARDIAC ENZYMES WERE TESTED PRIOR TO THE REPEAT REVASCULARIZATION. THE FOLLOWING DAY, CK WAS 74 (UNL 197, RATIO<1) AND TROPONIN I WAS 0.127 (UNL 0.034, RATIO 3.73). CKMB TESTING WAS NOT PERFORMED. THE CEC ADJUDICATED THIS TO A MYOCARDIAL INFARCTION (NOT REPORTED BY THE INVESTIGATOR). THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.
THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY. A TOTAL OF FOUR (4) STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE IN TWO TARGET LESIONS: THREE (3) CYPHER STENTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD)-A 2.5 X 28 MM (STENT #1), A 2.5 X 23 MM (STENT #2), AND A 3.0 X 23 MM (STENT #3) IN OVERLAPPING FASHION AT 16 ATM.; A XIENCE 3.0 X 28 MM STENT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX TARGET LESION. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. AT THE SIX-MONTH FOLLOW-UP CONTACT, THE PATIENT WAS REPORTED TO HAVE HAD A RE-PERCUTANEOUS CORONARY INTERVENTION (PCI) THE MID LAD TARGET LESION DUE TO RECURRENT ANGINA. THE EVENT WAS TREATED BY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE EVENT WAS REPORTED TO BE MODERATE IN SEVERITY, NOT RELATED TO THE STUDY INDEX PROCEDURE AND A PROBABLE RELATIONSHIP TO THE THREE (3) PREVIOUSLY IMPLANTED CYPHER STENTS. THE EVENT WAS REPORTED TO BE RESOLVED WITHOUT SEQUALAE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | 15090703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| R | 2.50 X 15MM BALLOON CATHETER |